Personal Catheter™ Intermittent Catheter 63316Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741069185), received between Aug 16, 2018 and Apr 8, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Use of Device Problem; Material Integrity Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT INSERTED THE CATHETER WITHOUT LUBRICANT . IT WAS DIFFICULT TO INSERT AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 9934142 ↗
• MalfunctionMar 17, 2020Manufacturing, Packaging or Shipping Problem; Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT¿S AUTHORIZED WIFE STATED 10 OF THE CATHETERS HAD NOTICEABLE BURRS ON THE EYELETS, WHICH CAUSED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 9841671 ↗
• InjuryAug 20, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED IRRITATION TO THE URETHRA AND A URINARY TRACT INFECTION WHILE USING THE CATHETER. THE PATIENT VISITED HIS UROLOGIST AND WAS PRESCRIBED LEVOFLOXACIN TO TREAT THE URINARY TRACT INFECTION.

  Patient problems: Irritation; Pain; Urinary Tract Infection

  MAUDE report 7798391 ↗
• MalfunctionAug 16, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7788333 ↗